A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of … (NCT07204964) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above
United States, Belgium971 participantsStarted 2025-10-07
Plain-language summary
The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
. Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
. A male or female at least 18 YOA at the time of the screening.
. Healthy participants or medically stable patients as established by medical history, and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, neurologic, and hematologic diseases) are allowed to participate in this study, if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
. Female participants of non-childbearing potential may be enrolled in the clinical study.
. Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
. Body mass index (BMI) between18 kg/m\^2 and 33kg/m\^2.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Timeframe: At Day 29
2
Geometric Mean Increase (GMI) of Antigen 1 Titer
Timeframe: From Day 1 to Day 29
3
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Timeframe: From Day 1 to Day 29
4
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Timeframe: At Day 1 and Day 29
5
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Timeframe: From Day 1 to Day 7
6
Number of Participants with Solicited Systemic AEs
. Where applicable, FDA toxicity grades will be exclusionary.
. Current or chronic conditions related with EXC criteria 1.
. Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
. History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
. Hypersensitivity to latex.
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
. History of hypersensitivity or allergic reaction to any previous influenza vaccine.
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From Day 1 to Day 181 (study end)
9
Number of Participants with Adverse Events of Special Interest (AESIs)
Timeframe: From Day 1 to Day 181 (study end)
10
Number of Participants with Medically Attended Adverse Events (MAAEs)
Timeframe: From Day 1 to Day 181 (study end)
11
Number of Participants with any Laboratory abnormalities